Tag: Novel food

Once commonly used for its anti-inflammatory effects in Europe, serratiopeptidase is no longer legally sold for human consumption in the EU and UK, following its classification as an unauthorized novel food under regulatory changes. The shift means that without a formal safety assessment and authorization, it cannot be legally placed on the market as a food supplement.

In 2011, the pharmaceutical company Takeda voluntarily withdrew its serrapeptase product in Japan after postmarketing trials found it ineffective for its approved uses [1.7.3, 1.6.1]. This event casts a long shadow over the question: is serrapeptase banned in Europe?

Following a comprehensive safety assessment by the European Food Safety Authority (EFSA), the European Commission officially authorized magnesium L-threonate as a novel food in October 2024, effectively ending its previously unregulated status. This regulatory shift clarifies that far from being banned, **is magnesium threonate banned in Europe** is a misconception based on new, specific conditions for its market access.